Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

NCT03354598 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: IT001-301
• Study Type: interventional
• Target: 1,671
• Locations: 1 country
• Sites: 60

Brief Summary

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women

Conditions

Uncomplicated Urinary Tract Infections

Outcome Measures

Primary Outcomes (2)

• Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success

  Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)

  Day 12+/-1 day

• Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success

  Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen)

  Day 12 +/- 1 day

Secondary Outcomes (1)

• Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success

  Day 12+/-1 day

Other Outcomes (1)

• Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Overall Success

  12 +/- 1 day

Study Arms (2)

Sulopenem-etzadroxil/probenecid

EXPERIMENTAL

Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days

Drug: Sulopenem-Etzadroxil/Probenecid

Ciprofloxacin

ACTIVE COMPARATOR

Ciprofloxacin 250 mg PO administered twice daily for 3 days

Drug: Ciprofloxacin

Interventions

Sulopenem-Etzadroxil/Probenecid DRUG

Treatment of uncomplicated urinary tract infection

Sulopenem-etzadroxil/probenecid

Ciprofloxacin DRUG

Treatment of uncomplicated urinary tract infection

Also known as: Cipro

Ciprofloxacin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females are eligible for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)
• Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain
• A mid-stream urine specimen with:
• a dipstick analysis positive for nitrite AND
• evidence of pyuria as defined by either:
• i. a dipstick analysis positive for leukocyte esterase ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine iii. White blood cell count ≥10 cells/high-powered field in the sediment of a spun urine
• Has given written informed consent to participate in the study.

You may not qualify if:

• Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature \> 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
• Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
• Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI
• Patients with ileal loops or urinary stoma
• Patients with an indwelling urinary catheter in the previous 30 days
• Patients with paraplegia
• Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
• Any history of trauma to the pelvis or urinary tract
• Patient's urine culture, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
• Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
• Known history of creatinine clearance \<50 mL/min
• Patients known to have liver disease
• Patients who are pregnant, or females of child-bearing age unable to take adequate contraceptive precautions
• Patients with uncontrolled diabetes mellitus
• Patients with history of blood dyscrasias

Sponsors & Collaborators

• Iterum Therapeutics, International Limited: lead

Study Sites (60)

Medical Facility

Birmingham, Alabama, 35242, United States

Location

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Phoenix, Arizona, 85032, United States

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Tolleson, Arizona, 85353, United States

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Cerritos, California, 90703, United States

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Chula Vista, California, 91911, United States

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Fullerton, California, 92835, United States

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La Mesa, California, 91942, United States

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Los Angeles, California, 90057, United States

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San Diego, California, 92108, United States

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Sylmar, California, 91342, United States

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Washington D.C., District of Columbia, 20011, United States

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Bradenton, Florida, 34209, United States

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Clearwater, Florida, 33761, United States

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Doral, Florida, 33166, United States

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Edgewater, Florida, 32132, United States

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Hialeah, Florida, 33012, United States

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Lauderdale Lakes, Florida, 33319, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33145, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33172, United States

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Miami, Florida, 33173, United States

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Miami Springs, Florida, 33166, United States

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New Port Richey, Florida, 34653, United States

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Ormond Beach, Florida, 32174, United States

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Palmetto Bay, Florida, 33157, United States

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St. Petersburg, Florida, 33711, United States

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Winter Haven, Florida, 33880, United States

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Atlanta, Georgia, 30312, United States

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Norcross, Georgia, 30092, United States

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Perry, Georgia, 31069, United States

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Lake Charles, Louisiana, 70601, United States

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Metairie, Louisiana, 70115, United States

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New Orleans, Louisiana, 70115, United States

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Las Vegas, Nevada, 89109, United States

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Las Vegas, Nevada, 89121, United States

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Brooklyn, New York, 11215, United States

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Raleigh, North Carolina, 27612, United States

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Hugo, Oklahoma, 74743, United States

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Easley, South Carolina, 29640, United States

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Lancaster, South Carolina, 29720, United States

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Myrtle Beach, South Carolina, 29572, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78735, United States

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Carrollton, Texas, 75010, United States

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Corpus Christi, Texas, 78414, United States

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Dallas, Texas, 75204, United States

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Houston, Texas, 77029, United States

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Houston, Texas, 77036, United States

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Pearland, Texas, 77584, United States

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Plano, Texas, 75024, United States

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Sugar Land, Texas, 77478, United States

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Bountiful, Utah, 84010, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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South Jordan, Utah, 84095, United States

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Medical Facility

St. George, Utah, 84790, United States

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Related Publications (1)

• Dunne MW, Aronin SI, Das AF, Akinapelli K, Zelasky MT, Puttagunta S, Boucher HW. Sulopenem or Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infections in Women: A Phase 3, Randomized Trial. Clin Infect Dis. 2023 Jan 6;76(1):66-77. doi: 10.1093/cid/ciac738.

  PMID: 36069202 DERIVED

MeSH Terms

Interventions

Probenecid; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Director, Clinical Development
• Organization: Iterum Therapeutics

saronin@iterumtx.com

18606614035

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 28, 2017
• Study Start: August 1, 2018
• Primary Completion: January 16, 2020
• Study Completion: January 20, 2020
• Last Updated: January 12, 2021
• Results First Posted: December 17, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (60)